The answer to this question is a difficult one but in many cases it is negative. Although clinical trials protocols are designed by scientists and physicians often they are very restrictive. Of course some of the reasons for these restrictions are to eliminate any possible risks for the patients. But this could also cause serious complications for patients and clinical trials teams, which are responsible to follow them. Such restrictions are often not overseen properly by the clinical trials teams at the set up stage.
What are the common protocol restrictions?
- Inadequate treatment windows – Some protocols have very limited treatment window of 1-2 days. Often that kind of protocols do not take into consideration that patients may not be able to attend within the given time or clinical trials team may not be able to fit the patient in their busy schedule.
- Inadequate imaging requirements – Radiology teams are very busy and have waiting lists. Often imaging requirements, which are not part of standard of care, could be a serious challenge for radiology teams.
- Inadequate drug administration times – Some protocols limit the time between drug preparation and administration in a range of minutes. However, often pharmacy teams are located outside of hospitals or in a long distance from treating teams. It could be a serious challenge for the teams to meet such requirements.
- Self administration – Not all patients will be happy to administer the medications themselves. Additional arrangements have to be made in such cases.
- Inadequate drug storage conditions – Some medications may require storage at -70C. Although this could be important for drug storage, it causes serious issues to pharmacy teams who may not be equipped to store and handle such medications.
What are the consequences?
- Significant amount of protocol violations and compliance issues, which could harm clinical trials teams` reputation.
- Missing data for medication safety profile analysis.
- Frustration and increased workload for clinical trials teams.
- High drop out rate
- Poor recruitment.
What could be done?
Although clinical trials teams cannot change the protocols they can raise any potential issues at early stage and make sure these issues are addressed before committing to the study. It will be unrealistic to expect that all protocols will follow standard of care requirements but if they bias significantly from the hospital practices, this should be discussed with all teams involved.
Author: Olga Peycheva
Olga is a clinical research professional who has been working in clinical research since 2005. She has extensive experience in clinical research in Eastern and Western Europe.
Originally published on 5 Jan 2015